FDA panel approves first biosimilar drug

The Food and Drug Administration approved its first biosimilar product last week, opening the door for more costly drug alternatives.

Sandoz's Zarxio is similar to Amgen Inc.'s Neupogen, which is used for cancer patients. Other examples of well-known biologic drugs are Remicade for treatment of rheumatoid arthritis or Herceptin and Avastin for cancer treatment.

Express Scripts said the introduction of Zarxio in the United States could save $5.7 billion in drug costs over the next decade, the New York Times reported.

A biosimilar product can be approved only by the FDA if it has the same form of action, route of administration, dosage and strength as the original medication, and can only be used for the specific conditions, the agency said.

Masimo has received FDA 510(k) clearance and market release of Rad-97™ Pulse CO-Oximeter. This includes configurations with the integrated NomoLine™ capnography and noninvasive blood pressure (NIBP) measurement from SunTech Medical.